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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
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Panelists noted that the underlying basis of an alternative methodology could be to re-examine the assumption of constant utilization over time. Unlike the current outlier methodology that predicts FDL amounts using a single year of claims data, this approach allows for the modeling of the MAP
amounts as they change over a longer period of time. CMS has received a number of suggested techniques that could be employed to reach the 1.0
percent target more predictably.
One of these suggestions is a calculation of after the fact FDLs that would achieve the 1.0 percent outlier target for each year included in the FDL
calculation. This has been referred to as the retrospective FDL, which would be lower than the FDLs published in the final rule for each corresponding year.
This calculation would be used for future outlier calculations. For more information, please refer to the TEP
reports here: https www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/ESRDpayment/Educational_
Resources.
Data presented during the TEP
meeting showed that using the three most recent years to simulate FDLs and outlier payments for 2020 resulted in an FDL amount for adults of $33.83 and a MAP amount of $37.41, respectively. By contrast, the 2020 FDLs and MAPs published in the CY 2020 ESRD PPS
final rule 84 FR 60649 were $48.33
and $35.78, respectively. The simulated outlier percentage for 2020 using the alternative methodology was 0.8
percent. The actual outlier payment percentage made for 2020 claims was 0.6 percent. Therefore, the alternative methodology results in an outlier percentage that is closer to the 1.0
percent target in the adult population.
6. Request for Information CMS is considering potential revisions to the calculation of the outlier threshold to address stakeholder concerns, and is issuing a request for information both to seek feedback on the approach suggested above, and to solicit information that will better inform future modifications to the methodology. In addition to any other input the public wants to provide for calculating the outlier payment adjustment, we are requesting responses to the following questions.
An alternative approach could be to estimate the retrospective FDL trend by using historical utilization data. The example above was constructed by using 20162018 data. There is flexibility in the time used to estimate this trend. The data must contain at least 2 years worth of claims data and
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may begin as early 2011. Additionally, it must end with the most recent year with complete data typically 2 years before the year in which the FDL will take effect.300
++ How many years of data should be included in calculation of this trend to best capture changes in treatment patterns?
The simulation of the FDL can be improved by better anticipating changes in utilization of ESRD outlier services.
What are the factors that affect the use of ESRD outlier services over time, and to what extent should CMS try to forecast the effect of these factors?
ESRD beneficiaries can now choose to enroll in Medicare Advantage.
++ Please describe any anticipated effects of this enrollment change on the use of ESRD outlier services in the ESRD PPS.
Adoption of the suggested methodology may account for systematic changes in the use of highcost outlier items. However, inherently unpredictable changes may still push the outlier payment off the 1.0 percent target.
++ Please comment on the acceptability of the below payment adjustment methods.
++ Payment reconciliationin the form of an add-on payment adjustment or a payment reductionmight be necessary to bring payments in line with the 1 percent target.
++ An add-on payment adjustment would be distributed after sufficient data reveal the magnitude of the deviation 1 year after the end of the payment year. The distribution of these monies could be done via a lump sum or via a per-treatment payment add-on effective for 1 year. This add-on payment adjustment would be paid irrespective of the outlier claim status in that year.
++ A payment reduction could take the form of a reduction in the base rate, also to be applied 1 year after the end of the payment year.
F. Calculation of the Pediatric Dialysis Payment Adjustment 1. Background on the Pediatric Dialysis Payment Adjustment Section 1881b14DivI of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate, such as a payment adjustment for pediatric providers of services and renal dialysis facilities.
300 The example uses CY 2020 to judge the performance of the alternative methodology. The most recent year with complete data when the 2020
FDL was determined was 2018.

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Below we discuss the current ESRD PPS
with regard to ESRD facilities that furnish renal dialysis services to pediatric patients, and request information on specific approaches as well as other topics related to developing a pediatric payment adjustment under the ESRD PPS.
Prior to implementation of the ESRD
PPS, payment for dialysis treatments was made through a composite rate per treatment that was based on cost report data and did not account for differences among patients with ESRD 48 FR
21254. The initial payment rates were established at $127 per treatment for independent facilities and $131 for hospital-based facilities, which reflect the costs incurred by dialysis facilities furnishing outpatient maintenance dialysis, including some routinely provided drugs, laboratory tests, and supplies, whether furnished by hospitalbased and independent facilities in a facility or at home.
In addition, we provided a process under which facilities with costs per treatment in excess of their composite rates could seek exceptions to those rates under specified circumstances in 413.182 and 413.184. For example, when a substantial proportion of the facilitys outpatient maintenance dialysis treatments involve atypically intense dialysis services, special dialysis procedures, or supplies necessary to meet special medical needs of the facilitys patients could qualify for an exception rate. Under 413.182, CMS could approve exceptions if the facility demonstrates, by convincing objective evidence, that its total per treatment costs are reasonable and allowable under the relevant cost reimbursement principles of part 413
and that its per treatment costs in excess of its payment rate are directly attributable to its patient mix. As a result of these provisions, many pediatric facilities secured an exception rate and were paid the exception rate until the transition to the ESRD PPS
ended in CY 2014.
Section 1881b12 of the Act, added by section 623d of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 MMA
required the Secretary to implement a basic case-mix adjustment to an ESRD
facilitys composite payment rate reflecting a limited number of patient characteristics. On August 5, 2004 and November 15, 2004, we published a proposed rule and final rule with comment period 69 FR 47487 through 47730 and 69 FR 66235 through 66915, respectively, implementing the provisions affecting the composite payment system. The development and
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